CONGRATS Grammy!

[LeelaLo]

What fantastic news Grammy, well done! I'm in Oz, and on 48 week triple therapy with Telaprivir, Rib and Interferon, but am struggling so much that I'm contemplating stopping and waiting for the newer orals (type 1a, it would be sofosbuvir and Ledipasvir) which shouldn't be too far away (tho $$$$!) here. My question for you is what OFF LABEL involves? Here my Dr says that even if I wait for Sofosbuvir they will still give Interferon to save on costs.....anyway, congratulations from the bottom of my heart, what a wonderful weight off our shoulders! Live long and happy!
LeelaLo x

[Michigan57]

I am starting the same treatment on Monday!  I am Geno 1a, never treated before and am very hopeful.  If you have any tips or info to share, please include me in your posts!

[pooh55811]

"Just to clarify the off label scenario, it would only apply to drugs that have actually been approved by eg the FDA, and not drugs (like Sovaldi/ledipasvir combo pill) that are waiting for approval? "
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That is correct.

[LeelaLo]

Just to clarify the off label scenario, it would only apply to drugs that have actually been approved by eg the FDA, and not drugs (like Sovaldi/ledipasvir combo pill) that are waiting for approval?

[LeelaLo]

Thanks Flyinlynn, that's clarified much for me! Also, it sounds as though you REALLY DESERVE this new combo, after three unsuccessful times around the block with no joy - good luck, I hope the powers that be co-operate for you! As for me, you have clarified what I already suspected was the case, that I would be precluded from this particular treatment, having treated with Incivek which is a protease inhibitor like the Simeprivir (and so I would have a resistance) BUGGER!! My options are greatly reduced and narrowed after taking a protease inhibitor! Anyway, thanks again, and best best of luck accessing the miracle drugs! LeelaLo x

[flyinlynn]

http://en.wikipedia.org/wiki/Off-label_use

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration.[1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most study of off-label use centers on prescription drugs. Off-label use is generally legal unless it violates specific ethical guidelines or safety regulations, but it does carry health risks and differences in legal liability

[flyinlynn]

All I can say is Go GrammyA, Go Grammy, Go Grammy !!!


I hope to follow you soon!

[flyinlynn]

Hi LeelaLo
I believe here in the US the decision for Solvaldi Olysio in combo is basen on your severity of illness, Genotype and responder status.

The American Assn for the Study of Liver Diseases AASLD Recommendations for Testing, Managing, and Treating Hepatitis C

http://www.hcvguidelines.org/full-report-view

The recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:

Daily sofosbuvir plus simeprevir, with or without weight-based RBV for 12 weeks is recommended for retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility

I hopefully will hear soon from my Dr if my insurance will ok this for me.

I am 55 yo female GT 1a,  3 times tx null responder with F4 cirrhosis. All that improves my chances of getting the off label combo.

For patients who are less ill they may have to wait or persue other options.

Ledipasvir/Sovaldi combo pill all oral tx Gilead just submitted for FDA approval a few days ago. But that medication is still months away from being available

Good Luck

[LeelaLo]

Sounds like an awesome treatment Grammy, go for it! They really are miracle drugs it seems! Sorry if I'm a bit dense, but I actually don't know what OFF LABEL means, how you can get that from your doctor? Anyway, lovely to hear you're doing so well, I'll be watching your story wishing you all the best in the world! LeelaLo x

[GrammyA]

My Off label is just taking 2 pills each day - 1 is Olysio and 1 is Sovaldi.  That is it- nothing else. 12 weeks ONLY!!!  Remember I am 1b with cirrhosis and 61 years old.  Thank you for your kind words and I hope you can get on this combo also if your doctor thinks it might work for you too.
HUGS!!